Bob Bryan and Timothy Bennett discussed how to develop a strategic approach for the upcoming regulatory changes outlined in HTI-1, focusing on compliance and readiness for 2025 and beyond.
Bob Bryan and John Valutkevich dive into the key marketplace factors shaping predictive DSI within certified Health IT. With EHRs and other certified Health IT systems working to meet the ONC’s new §170.315(b)(11) requirements, a pivotal question arises: how can the broader health care AI marketplace leverage the enhanced predictive DSI capabilities supported by these (b)(11)-compliant EHRs?
As health and life sciences industries continue to shift from paper to digital, CFR 21 Part 11, a regulation issued by the U.S. Food and Drug Administration (FDA), has become a cornerstone of compliant electronic recordkeeping. It defines how organizations must manage electronic records and signatures to ensure they are as trustworthy, reliable, and legally valid as their paper counterparts.
